repetitive transcranial magnetic stimulation (rtms) on neurogenic overactive bladder in stroke

Conditions: Urgency Urinary Incontinence; Overactive Bladder

Summary: neurogenic overactive bladder (noab) presents with urgency incontinence. existing noab management is expensive, lacks standardized regimens, or is invasive. therefore, evaluating the effectiveness of non-invasive repetitive transcranial magnetic stimulation (rtms) for noab management among stroke survivors remains crucial. objectives: evaluate the effects of active-rtms compared to sham-rtms among stroke survivors with noab, the interventions' cost-effectiveness and explore their experiences qualitatively.

summary background: neurogenic overactive bladder (noab) presents with urgency incontinence. existing noab management is expensive, lacks standardized regimens, or is invasive. therefore, evaluating the effectiveness of non-invasive repetitive transcranial magnetic stimulation (rtms) for noab management among stroke survivors remains crucial. objectives: evaluate the effects of active-rtms compared to sham-rtms among stroke survivors with noab, the interventions' cost-effectiveness and explore their experiences qualitatively. hypothesis: active-rtms will reduce noab symptom severity for stroke survivors, interventions' cost and assist in gaining insight into the noab patients' experiences. methods: this study will be a randomised-sham-controlled, double-blinded trial, with embedded qualitative and cost-effectiveness studies. snowball-convenience sampling technique and computer-generated randomisation will be adopted to recruit 30 participants into active-rtms and sham-rtms groups each. active-rtms participants will receive a continuous 1 pulse per second 1200 pulses of low-frequency rtms to the pelvic floor muscle representation in the contralesional primary motor cortex (m1) for 20 minutes thrice weekly. sham-rtms participants will receive the same parameters as the active-rtms group, however, the coil will be rotated 90° away from the scalp. fifteen active-rtms participants will be invited for 45-60 minutes focus group discussions. the primary and secondary outcomes will be urinary incontinence severity and quality of life evaluated using the overactive bladder symptom score and incontinence-quality of life questionnaire, respectively. quality-adjusted life-years (qaly) will be the cost-effectiveness outcome. the eq-5d-5l responses will estimate the gain or loss of qaly. a follow-up assessment will be conducted one-months post-intervention. the client service receipt inventory (csri) will be used to collect information on the whole range of services and support required by the study participants. statistical analysis: normality will be evaluated using shapiro-wilk test. to determine active-rtms and sham-rtms group differences, between-groups analysis of covariance (ancova) will be conducted using r software. bonferroni correction will be applied for multiple comparisons. thematic analysis will be used for analysing the qualitative data. for the cost-effectiveness analysis, the unadjusted mean costs and cost differences between active-rtms and the sham-rtms group will be calculated.

Eligibility criteria:
inclusion criteria: * stroke survivors aged between 18-80 years diagnosed with noab * urodynamic findings confirming detrusor overactivity * experience moderate (oabss scores: 6-11 points) to severe noab (oabss scores: 12 points and above) * obtain a mini-mental state examination (mmse) score of ≥ 24 * be willing to be randomized exclusion criteria: * presence of metals in the cranium, intracardiac lines, increased intracranial pressure, heart diseases, or cardiac pacemaker, use of sacral neuro-modulation * pregnancy or less than six months postpartum stage * patients with a family history of epilepsy or seizures * patients taking tricyclic antidepressants or neuroepileptics * participation in any other research project related to urinary incontinence; contra-indicated to mri, urologic cancer, prostatic pathology, severe pelvic pain, six weeks post-surgery and non-neurogenic bladder